Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 203629

Expand all

NEOSTIGMINE METHYLSULFATE (NEOSTIGMINE METHYLSULFATE)
3MG/3ML (1MG/ML)
Marketing Status: Prescription

Active Ingredient: NEOSTIGMINE METHYLSULFATE
Proprietary Name: NEOSTIGMINE METHYLSULFATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 3MG/3ML (1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N203629
Product Number: 003
Approval Date: Sep 18, 2018
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

NEOSTIGMINE METHYLSULFATE (NEOSTIGMINE METHYLSULFATE)
5MG/10ML (0.5MG/ML)
Marketing Status: Prescription

Active Ingredient: NEOSTIGMINE METHYLSULFATE
Proprietary Name: NEOSTIGMINE METHYLSULFATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 5MG/10ML (0.5MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203629
Product Number: 001
Approval Date: Jan 8, 2015
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

NEOSTIGMINE METHYLSULFATE (NEOSTIGMINE METHYLSULFATE)
10MG/10ML (1MG/ML)
Marketing Status: Prescription

Active Ingredient: NEOSTIGMINE METHYLSULFATE
Proprietary Name: NEOSTIGMINE METHYLSULFATE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 10MG/10ML (1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203629
Product Number: 002
Approval Date: Jan 8, 2015
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information